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Real Life Safety and Efficacy of Vardenafil

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ClinicalTrials.gov Identifier: NCT01215409
Recruitment Status : Terminated (Slow recruitment)
First Posted : October 6, 2010
Last Update Posted : May 19, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
In this uncontrolled, non-randomized, prospective, local post-marketed surveillance study, data are obtained on safety and efficacy of LEVITRA® in routine treatment of erectile dysfunction. The general objectives are to evaluate the product safety (primarily by recording adverse events), efficacy and patient acceptance.

Condition or disease Intervention/treatment
Erectile Dysfunction Drug: Vardenafil (Levitra, BAY38-9456)

Study Design

Study Type : Observational
Actual Enrollment : 372 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Vardenafil in Routine Treatment of Erectile Dysfunction
Study Start Date : February 2008
Primary Completion Date : November 2008
Study Completion Date : November 2008


Groups and Cohorts

Group/Cohort Intervention/treatment
Group 1 Drug: Vardenafil (Levitra, BAY38-9456)
5 mg or 10 mg or 20 mg of Vardenafil, orally when necessary for 2 months


Outcome Measures

Primary Outcome Measures :
  1. General assessment of patients concerning efficacy and tolerability of vardenafil treatment [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. Time to first intercourse after intake of vardenafil [ Time Frame: 2 months ]
  2. Percentage of successful second intercourse within 24 hours [ Time Frame: 2 months ]
  3. Percentage of participants who are willing to continue treatment [ Time Frame: 2 months ]
  4. Number of participants with adverse events [ Time Frame: 2 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinics
Criteria

Inclusion Criteria:

  • Any adult patient (>/=18 years) with erectile dysfunction treated with LEVITRA®.
  • Patients must be able to give written informed consent for participation in the study after receiving detailed written and oral information prior to the study.

Exclusion Criteria:

  • Exclusion criteria must be read in conjunction with the product information (Package Insert).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01215409


Locations
Taiwan
Many Locations, Taiwan
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01215409     History of Changes
Other Study ID Numbers: 14328
LV0611TW ( Other Identifier: Company internal )
First Posted: October 6, 2010    Key Record Dates
Last Update Posted: May 19, 2014
Last Verified: May 2014

Keywords provided by Bayer:
Levitra
Erectile dysfunction
Taiwan

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Vardenafil Dihydrochloride
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents